CHUNZAM BIO CO., LTD. · 66-79 · KOREA (THE REPUBLIC OF)
For CHUNZAM BIO CO., LTD., import alert is 66-79; country is KOREA (THE REPUBLIC OF); import alert name is "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"; product is All Drug and Drug Products; product code is 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 10/13/2022; address is 225 Wangsan-Ro , Dongdaemun, Seoul KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- CHUNZAM BIO CO., LTD. verified
- Import alert
- 66-79
- Import alert name
- "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 225 Wangsan-Ro , Dongdaemun, Seoul KOREA (THE REPUBLIC OF) verified
- Date published
- 10/13/2022 verified
- Product code
- 53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs each item verified
- Product
- All Drug and Drug Products verified
- FDA notes
- For 53I[][]01; only drug and drug products are subject to DWPE under this notice.; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 | All Drug and Drug Products; DWPE Date; 10/24/2018 each item verified
What the source says
CHUNZAM BIO CO., LTD. Date Published : 10/13/2022 225 Wangsan-Ro , Dongdaemun, Seoul KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products) Date Published: 10/28/2021 Desc: All Drug and Drug Products Notes: For 53I[][]01; only drug and drug products are subject to DWPE under this notice.; DWPE Date; 10/24/2018 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 56 - - - -- Antibiotics (Human/Animal) Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 61 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 62 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 63 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 64 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 65 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018 66 - - - -- Human and Animal Drugs Date Published: 10/28/2021 Notes: All Drug and Drug Products; DWPE Date; 10/24/2018
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1174.html